POLY Q (GARANT L, PENTA M, PENTA H)— 510(k) K032001

Name: FDA 510(k) clearance K032001
Creator: U.S. Food and Drug Administration
Published: 2003-08-11

Substantially Equivalent

3M Espe AG Dental Products

FDA 510(k) clearance K032001 for POLY Q (GARANT L, PENTA M, PENTA H), Substantially Equivalent on 2003-08-11. Applicant: 3M Espe AG Dental Products. Device class: 2.

Clearance details

Applicant: 3M Espe AG Dental Products
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2003-06-27
Decision date: 2003-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bavaria D-82228 Seefeld, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.